Outcomes and quality of life in patients with locally advanced cancers of vulva and vagina.

Not yet recruiting

Conditions: Malignant neoplasm of vulva, unspecified, (2) ICD-10 Condition: C52||Malignant neoplasm of vagina,

Brief Summary: The vaginal cancers are responsible for 2% of gynecological cancer while vulvar cancers account for 4 % of gynecological cancers. HPV 16 and 33 are most prevalent in vaginal cancers and account for more than half of cases HPV related vaginal cancer. However, adeqaute information is not there. Similarly, structured QOL data is not available for India. Therefore, in the proposed study we will like to systematically evaluate the patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy). The therapeutic research in vulvo-vaginal cancers has been relatively slow and such structured registration databases can allow analysis of large number of patients to report on acute and late effect of treatment outcomes using CTCAE and QOL (EORTC QLQ C-30 and VU-34) in rare cancers. We hope that we will get help in identifying thrust areas for future research including prospective interventional trials through this study.

Recruitment & Eligibility

Inclusion Criteria

Patients diagnosed with vulvo-vaginal cancer.
Patients treated with Radiation+/- chemotherapy +/- surgery from January 1, 2019- December 31, 2023.

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
To report patterns of relapse and disease outcomes in patients with vulvovaginal cancer treated with radiation (+/- chemotherapy): RFS, DFS	3 Years

Secondary Outcome Measures

Name	Time	Method
To report outcomes as a function of p16, AKT, PDL-1 expression.	5 Years
To report on acute and late effect of treatment outcomes using CTCAE.	5 Years
To report on longitudinal QOL using EORTC QLQ C-30 and VU-34 (English, Hindi, Marathi as applicable)	4,8,12,16,20,24,30,36,42,48, 54,60 months

Locations (1): Tata Memorial Hospital, Advance Centre for Treatment, Research and Education in Cancer
🇮🇳
Raigarh, MAHARASHTRA, India
Tata Memorial Hospital, Advance Centre for Treatment, Research and Education in Cancer
🇮🇳Raigarh, MAHARASHTRA, India
Dr Supriya Sastri
Principal investigator
9930958309
supriyasastri@gmail.com